Abnormalities, CardiovascularCVMRINCT00593541
Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging
An observational study of Abnormalities, Cardiovascular, run by University of California, Davis.
Trial summary
This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormalities, Cardiovascular
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Noraml volunteers and patients with known or suspected cardiovascular disease
Who may be able to join
- 18 years of age or older
- Ability to give informed, written consent
- Not Pregnant or breastfeeding
Who cannot join
- Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
- Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
- History of uncontrolled claustrophobia
About this study
This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.
Read the detailed description
This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities. This Protocol is not restricted to imaging of a particular organ system or disease. The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.
- Conditions
- Abnormalities, Cardiovascular
- Keywords
- MRI
- Medical subject headings
- Cardiovascular Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images
Measured: Post-scanning
Secondary outcomes (1)
Improve image quality by various techniques (e.g. reducing the effects of motion)
Measured: Post-scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 1999
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Principal Investigator is deceased
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities, CardiovascularStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Buonocore, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593541
- Sponsor's protocol ID
- 200210689
- Acronym
- CVMRI
- Status last verified
- May 2017
- First submitted
- 3 Jan 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00593541
- Acronym / sponsor ID
- CVMRI / 200210689
- Conditions
- Abnormalities, Cardiovascular
- Keywords
- MRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator is deceased
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.
Detailed description
This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities. This Protocol is not restricted to imaging of a particular organ system or disease. The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Noraml volunteers and patients with known or suspected cardiovascular disease
Key inclusion criteria (3 listed)
- 18 years of age or older
- Ability to give informed, written consent
- Not Pregnant or breastfeeding
Key exclusion criteria (3 listed)
- Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
- Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
- History of uncontrolled claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images
Time frame: Post-scanning
1 secondary outcome
Improve image quality by various techniques (e.g. reducing the effects of motion)
Time frame: Post-scanning
Results and safety
The study was stopped early (reason given: Principal Investigator is deceased). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Buonocore, MD, PhD principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormalities, Cardiovascular, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator is deceased). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images (time frame: Post-scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.